Quality Specialist - Thailand

About the Company

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. Our entrepreneurial adventure, begun over a century ago, is driven by an unrelenting commitment to improve public health worldwide. Since 1963, we've been paving the way in the field of in vitro diagnostics and have contributed greatly to improving public health and making the world a healthier place. The solutions that our teams imagine, develop and manufacture are key to enable healthcare professionals and industry players to make confident decisions to improve patient outcome and ensure consumer safety. It is today present in 44 countries, serves more than 160 countries with the support of a large network of distributors, and supported by more than 13,000 employees worldwide.

About the Role

Primary Purpose And Overall Objective Of The Job: To ensure quality compliance under applicable quality standards and bioMerieux corporate standards. This position serves as the QMR (Quality Management Representative) for bioMérieux Thailand subsidiary and supports ASEAN quality activities.

Responsibilities

• Act as QMR (Quality Management Representative) for bioMérieux Thailand subsidiary.
• Perform quality analysis on shipments (TTOR) after training and execute necessary release and coordination for shipment release as required.
• Manage and coordinate internal & external audits, supplier audits and distributor audits.
• Perform and support document control work including SOP drafting, revision, publishing, and related activities.
• Coordinate and monitor implementation of field actions and complaint handling.
• Manage and coordinate CAPA and vigilance activities.
• Support ASEAN activities including TTOR analysis, document control, internal & external audit, management review, CAPA, vigilance, change control and other QA activities as required for the region.

Qualifications

• Degree in bioscience, life science or biomedical engineering.
• Minimum 3 years' relevant experience in a QA environment.
• Familiar with or trained on ISO 9001:2015 and GDPMD / GDPMDS Quality Management System requirements.
• Familiarity with Trackwise / Trackwise Digital or other relevant quality platforms.
• Experience using problem-solving tools including fishbone diagrams, FMEA and 5-whys methodology preferred.
• Good analytical, communication and interpersonal skills; meticulous attention to detail and ability to multi-task.
• Smooth English speaker advantageous to liaise with cross-country stakeholders.